Hip DysplasiaNCT04039386
Psychosocial Interventions for Young Adults With Hip Pain
A study testing Cell Phone Based Cognitive Based Therapy (Pacifica App) in people with Hip Dysplasia and Hip Pain Chronic, run by Michael C Willey at 1 site in United States.
Trial summary
Psychosocial conditions are common in young adults with hip pain including depression, anxiety, pain catastrophizing, and narcotic use. The incidence of these conditions is not well defined. Interventions to optimize psychosocial conditions with non-surgical or surgical treatments has not been investigated. Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Hip Dysplasia, Hip Pain Chronic, Hip Osteoarthritis
- What is being tested?
- Cell Phone Based Cognitive Based Therapy (Pacifica App)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- We will enroll young adults (15-39) presenting to one of several physical therapy and orthopedic practices in the state of Iowa for treatment of nonarthritic hip pain.
- Chief complaint of hip pain or dysfunction, and a diagnosis of a nonarthritic hip condition including labral tear, femoroacetabular impingement (FAI), snapping hip, femoral anteversion or dysplasia.
Who cannot join
- Difficulty with written English
- Treatment for alternative conditions such as trochanteric bursitis, hip dislocation, avascular necrosis or fracture.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Iowa
Iowa City, Iowa, 52242
Michael C Willey, MD, 3193561616 ext. 3193561616, michael-willey@uiowa.edu
Michael C Willey, 3193561616 ext. 3193561616, michael-willey@uiowa.edu
About this study
Psychosocial conditions are common in young adults with hip pain including depression, anxiety, pain catastrophizing, and narcotic use. The incidence of these conditions is not well defined. Interventions to optimize psychosocial conditions with non-surgical or surgical treatments has not been investigated. The goal of this project is to determine the incidence of psychosocial conditions in the young adult population with hip pain and determine if cognitive based therapy can improve clinical outcomes in these individuals.
Read the detailed description
Over the last 3 decades there has been a drastic increase in the number of joint preservation surgeries performed for pre-arthritic hip conditions in the United States. Despite advances in surgical technique and the understanding of the biomechanics of impingement and dysplasia, failure rates range from 5-20% at early follow up, and can be even higher with continued monitoring. These failures are often attributed to the presence of pre-operative osteoarthritis, increased age, or unaddressed structural deformity. The influence of psychosocial factors on surgical and rehabilitative outcomes has been recognized in multiple populations, but has largely been ignored in individuals with hip pathology, in spite of growing recognition by clinicians as to how psychosocial factors may contribute to patient outcomes. Previous investigations have demonstrated poor mental health is associated with pre-operative narcotic use and lower physical function. Further, the investigators have identified certain psychiatric diagnoses as independent factors associated with failure of hip arthroscopy. Addressing these often complex psychosocial issues using cognitive based therapy has been successful in improving outcomes across a range of medical conditions. Further investigation into the incidence of these psychosocial conditions, their contributions to surgical and non-surgical outcomes, and interventions for mental health optimization need to be performed in musculoskeletal medicine, specifically in the developing field of hip preservation surgery. The goal of this project is to (1) understand the burden of maladaptive psychosocial traits in young adult patients with hip pain, and (2) reduce pain, decrease narcotic use, and improve physical function through psychosocial intervention delivered concomitantly during physical therapy. The investigators seek to maximize outcomes of individuals with non-arthritic hip dysfunction by addressing maladaptive behaviors so subjects can more effectively participate in rehabilitative treatment, and potentially, avoid the need for surgical management.
- Being tested
- Cell Phone Based Cognitive Based Therapy (Pacifica App), Control
- Keywords
- Hip Pain, Hip Instability, Hip Impingement, Cognitive Based Therapy, Psychosocial Conditions
- Medical subject headings
- Hip Dislocation, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell Phone Based Cognitive Based Therapy (Pacifica App)Device
Cell phone application that provides support for individuals with psychosocial conditions.
ControlOther
Also called Standard Care
Subjects in the control group will receive standard care.
| Study group | Role | What they receive |
|---|---|---|
| Cell Phone Based Cognitive Based Therapy | Experimental | Young adults with hip pain Receives: Device: Cell Phone Based Cognitive Based Therapy (Pacifica App) |
| Placebo | Placebo comparator | Young adults with hip pain Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in level of Depression (DASS-21)
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire
- General adult population average total score: 9.43 (standard deviation (SD) 9.66), out of a total possible score of 63 points,
- Indication of significant difference from normative data: Average score >1 SD above the General adult population average total score
- General adult population average depression sub scale score: 2.83 (SD 3.87)
- Values above 9.03 points in the depression subsection score correlate with clinical depression and generalized anxiety disorders
- A change of 3.86 or more points in the depression subscore reliably represents clinical improvement.
Measured: 8 weeks
Changes in level of Depression (PROMIS)
Assessed using the Patient Reported Outcome Measures Information (PROMIS): Depression. An electronically administered patient reported outcome questionnaire
- Normative T-score generated from US adult population data: mean 50 (SD 10).
- For this study, an average T-score <40 would be considered significantly different compared to normative values.
- The minimally important difference (MID) of 3.0-3.1 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
Measured: 8 weeks
Changes in level of Anxiety (DASS-21)
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire
- General adult population average total score: 9.43 (SD 9.66)
- An average total score >1 SD above the mean would be considered significantly different from normative data
- General adult population average anxiety subscale scores: 1.88±2.95
- Average anxiety subsection score above 6.27 correlate with clinical depression and generalized anxiety disorders
- A change of 3.85 or more points in the anxiety subscore reliably represents clinical improvement.
Measured: 8 weeks
Changes in level of Anxiety (PROMIS)
Assessed using the Patient Reported Outcome Measures Information (PROMIS): Anxiety. An electronically administered patient reported outcome questionnaire
- Normative T-score generated from US adult population data: mean 50 (SD 10).
- For this study, an average T-score <40 would be considered significantly different compared to normative values.
- The minimally important difference (MID) of 2.3 to 3.4 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
Measured: 8 weeks
Changes in level of Stress (DAAS-21)
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire
- General adult population average total score: 9.43 (SD 9.66)
- An average total score >1 SD above the mean would be considered significantly different from normative data
- General adult population average stress subscale scores: 4.73±4.20
- Average stress subsection score above 12.27 correlate with clinical depression and generalized anxiety disorders
- A change of 4.90 or more points in the anxiety subscore reliably represents clinical improvement.
Measured: 8 Weeks
Evaluating the presence and severity of Kinesiophobia
Assessed via the Shortened Tampa Scale for Kinesiophobia (TSK-11) electronically administered patient reported outcome questionnaire
- The survey is a 11-question test scored from 11-44, where higher scores indicate increasing fear of movement.
- A value of 11 is presumed in a nonpainful population.
- Adults with chronic musculoskeletal pain undergoing outpatient chronic pain therapy report an average TSK score of 30.4 (+/- 6.6).
- Successful evaluation of Kinesiophobia will be indicated if increases in TSK-11 scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use.
- The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Measured: 8 weeks
Evaluation of Resiliency
Assessed via The Brief Resiliency Scale (BRS) electronically administered patient reported outcome questionnaire
- An 8 question survey scored from 1-5 points
- The average score for US adults age 24-34 is 3.2 (SD 0.7)
- A statistically significant lower Grit score would be >1SD below this average value.
- Successful evaluation of Grit will be indicated if increases in GRIT-S scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use.
- The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Measured: 8 weeks
Evaluation of Grit
Assessed via The Short Grit Scale (GRIT-S) electronically administered patient reported outcome questionnaire
- A 6-question test with low resiliency defined as a score of <3.00.
- Prior descriptive studies indicate an average score of 3.57 (SD 0.76) for young adults age 19.8±3.0 years.
- Statistically significant lower resilience would be >1SD below this average value.
- Successful evaluation of Resiliency will be indicated if increases in GRIT-S scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use.
- The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents (for those tests where this data exists) would also be considered a successful finding.
Measured: 8 weeks
Evaluating the presence and severity of Pain Catastrophizing
Assessed via Pain Catastrophizing Scale (PCS) electronically administered patient reported outcome questionnaire
- Scored on a 13 point scale.
- Normative average values from a population of adults adults age 42.2 (17-63 years) with low back pain: mean 20.90 (SD 12.5),
- Successful evaluation of Pain Catastrophization will be indicated if increases in PCS scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use.
- The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Measured: 8 weeks
Evaluating Self-Efficacy
Assessed via The General Self-Efficacy Scale (GSE) electronically administered patient reported outcome questionnaire
- 10-question test, scored from 10-40, with lower scores representing low self efficacy.
- Average US adult values: 29.48 (SD 5.13)
- Successful evaluation of Self-Efficacy will be indicated if increases in GSE scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use.
- The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Measured: 8 weeks
Evaluating the presence and severity of Alcohol Use Disorders
Assessed via Alcohol Use Disorders Identification Test (AUDIT) electronically administered patient reported outcome questionnaire
- A 10-question test with a threshold score >7 considered "AUDIT-positive", indicating risky or hazardous alcohol use behavior.
- National data suggests 15-20% of US 14-18 year olds screen positive
- Successful evaluation of Alcohol Use Disorders will be indicated if increases in AUDIT scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use.
- The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Measured: 8 weeks
Changes in Physical Function (PROMIS)
Measured via the following electronically administered patient reported outcome questionnaires.
- PROMIS: Physical Function (PF)
- Normative T-score generated from US adult population data: mean 50 (SD 10).
- For this study, an average T-score <40 would be considered significantly different compared to normative values.
- The minimally important difference (MID) of 1.9 - 2.2 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
Measured: 8 weeks
Changes in Physical Function (HOOS)
Measured via the following electronically administered patient reported outcome questionnaires.
- The Hip disability and osteoarthritis outcome score (HOOS)
- Scored from 0-100
- Increasing score represent better function.
- Average scopres for hip preservation patients prior to surgery is well established
Measured: 8 weeks
Reduced Opioid Use
Measured via self reported opioid use after surgery
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Sep 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael C Willey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael C Willey, University of Iowa
- Investigators
- Elizabeth Scott, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039386
- Sponsor's protocol ID
- 1111
- Status last verified
- Apr 2026
- First submitted
- 16 May 2019
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Interventions for Young Adults With Hip Pain
- ClinicalTrials.gov ID
- NCT04039386
- Acronym / sponsor ID
- 1111
- Keywords
- Hip Pain, Hip Instability, Hip Impingement, Cognitive Based Therapy, Psychosocial Conditions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Michael C WilleyUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psychosocial conditions are common in young adults with hip pain including depression, anxiety, pain catastrophizing, and narcotic use. The incidence of these conditions is not well defined. Interventions to optimize psychosocial conditions with non-surgical or surgical treatments has not been investigated. The goal of this project is to determine the incidence of psychosocial conditions in the young adult population with hip pain and determine if cognitive based therapy can improve clinical outcomes in these individuals.
Detailed description
Over the last 3 decades there has been a drastic increase in the number of joint preservation surgeries performed for pre-arthritic hip conditions in the United States. Despite advances in surgical technique and the understanding of the biomechanics of impingement and dysplasia, failure rates range from 5-20% at early follow up, and can be even higher with continued monitoring. These failures are often attributed to the presence of pre-operative osteoarthritis, increased age, or unaddressed structural deformity. The influence of psychosocial factors on surgical and rehabilitative outcomes has been recognized in multiple populations, but has largely been ignored in individuals with hip pathology, in spite of growing recognition by clinicians as to how psychosocial factors may contribute to patient outcomes. Previous investigations have demonstrated poor mental health is associated with pre-operative narcotic use and lower physical function. Further, the investigators have identified certain psychiatric diagnoses as independent factors associated with failure of hip arthroscopy. Addressing these often complex psychosocial issues using cognitive based therapy has been successful in improving outcomes across a range of medical conditions. Further investigation into the incidence of these psychosocial conditions, their contributions to surgical and non-surgical outcomes, and interventions for mental health optimization need to be performed in musculoskeletal medicine, specifically in the developing field of hip preservation surgery. The goal of this project is to (1) understand the burden of maladaptive psychosocial traits in young adult patients with hip pain, and (2) reduce pain, decrease narcotic use, and improve physical function through psychosocial intervention delivered concomitantly during physical therapy. The investigators seek to maximize outcomes of individuals with non-arthritic hip dysfunction by addressing maladaptive behaviors so subjects can more effectively participate in rehabilitative treatment, and potentially, avoid the need for surgical management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell Phone Based Cognitive Based Therapy | Experimental | Device: Cell Phone Based Cognitive Based Therapy (Pacifica App)Young adults with hip pain |
| Placebo | Placebo comparator | Other: ControlYoung adults with hip pain |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- We will enroll young adults (15-39) presenting to one of several physical therapy and orthopedic practices in the state of Iowa for treatment of nonarthritic hip pain.
- Chief complaint of hip pain or dysfunction, and a diagnosis of a nonarthritic hip condition including labral tear, femoroacetabular impingement (FAI), snapping hip, femoral anteversion or dysplasia.
Key exclusion criteria (2 listed)
- Difficulty with written English
- Treatment for alternative conditions such as trochanteric bursitis, hip dislocation, avascular necrosis or fracture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell Phone Based Cognitive Based Therapy (Pacifica App)Cell phone application that provides support for individuals with psychosocial conditions. | Device | Cell Phone Based Cognitive Based Therapy |
| ControlAlso: Standard CareSubjects in the control group will receive standard care. | Other | Placebo |
Primary outcome
Changes in level of Depression (DASS-21)
Time frame: 8 weeks
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire * General adult population average total score: 9.43 (standard deviation (SD) 9.66), out of a total possible score of 63 points, * Indication of significant difference from normative data: Average score >1 SD above the General adult population average total score * General adult population average depression sub scale score: 2.83 (SD 3.87) * Values above 9.03 points in the depression subsection score correlate with clinical depression and generalized anxiety disorders * A change of 3.86 or more points in the depression subscore reliably represents clinical improvement.
Changes in level of Depression (PROMIS)
Time frame: 8 weeks
Assessed using the Patient Reported Outcome Measures Information (PROMIS): Depression. An electronically administered patient reported outcome questionnaire * Normative T-score generated from US adult population data: mean 50 (SD 10). * For this study, an average T-score <40 would be considered significantly different compared to normative values. * The minimally important difference (MID) of 3.0-3.1 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
Changes in level of Anxiety (DASS-21)
Time frame: 8 weeks
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire * General adult population average total score: 9.43 (SD 9.66) * An average total score >1 SD above the mean would be considered significantly different from normative data * General adult population average anxiety subscale scores: 1.88±2.95 * Average anxiety subsection score above 6.27 correlate with clinical depression and generalized anxiety disorders * A change of 3.85 or more points in the anxiety subscore reliably represents clinical improvement.
Changes in level of Anxiety (PROMIS)
Time frame: 8 weeks
Assessed using the Patient Reported Outcome Measures Information (PROMIS): Anxiety. An electronically administered patient reported outcome questionnaire * Normative T-score generated from US adult population data: mean 50 (SD 10). * For this study, an average T-score <40 would be considered significantly different compared to normative values. * The minimally important difference (MID) of 2.3 to 3.4 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
Changes in level of Stress (DAAS-21)
Time frame: 8 Weeks
Assessed using the Depression Anxiety Stress Scale (DASS-21) electronically administered patient reported outcome questionnaire * General adult population average total score: 9.43 (SD 9.66) * An average total score >1 SD above the mean would be considered significantly different from normative data * General adult population average stress subscale scores: 4.73±4.20 * Average stress subsection score above 12.27 correlate with clinical depression and generalized anxiety disorders * A change of 4.90 or more points in the anxiety subscore reliably represents clinical improvement.
Evaluating the presence and severity of Kinesiophobia
Time frame: 8 weeks
Assessed via the Shortened Tampa Scale for Kinesiophobia (TSK-11) electronically administered patient reported outcome questionnaire * The survey is a 11-question test scored from 11-44, where higher scores indicate increasing fear of movement. * A value of 11 is presumed in a nonpainful population. * Adults with chronic musculoskeletal pain undergoing outpatient chronic pain therapy report an average TSK score of 30.4 (+/- 6.6). * Successful evaluation of Kinesiophobia will be indicated if increases in TSK-11 scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. * The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Evaluation of Resiliency
Time frame: 8 weeks
Assessed via The Brief Resiliency Scale (BRS) electronically administered patient reported outcome questionnaire * An 8 question survey scored from 1-5 points * The average score for US adults age 24-34 is 3.2 (SD 0.7) * A statistically significant lower Grit score would be >1SD below this average value. * Successful evaluation of Grit will be indicated if increases in GRIT-S scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. * The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Evaluation of Grit
Time frame: 8 weeks
Assessed via The Short Grit Scale (GRIT-S) electronically administered patient reported outcome questionnaire * A 6-question test with low resiliency defined as a score of <3.00. * Prior descriptive studies indicate an average score of 3.57 (SD 0.76) for young adults age 19.8±3.0 years. * Statistically significant lower resilience would be >1SD below this average value. * Successful evaluation of Resiliency will be indicated if increases in GRIT-S scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. * The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents (for those tests where this data exists) would also be considered a successful finding.
Evaluating the presence and severity of Pain Catastrophizing
Time frame: 8 weeks
Assessed via Pain Catastrophizing Scale (PCS) electronically administered patient reported outcome questionnaire * Scored on a 13 point scale. * Normative average values from a population of adults adults age 42.2 (17-63 years) with low back pain: mean 20.90 (SD 12.5), * Successful evaluation of Pain Catastrophization will be indicated if increases in PCS scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. * The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Evaluating Self-Efficacy
Time frame: 8 weeks
Assessed via The General Self-Efficacy Scale (GSE) electronically administered patient reported outcome questionnaire * 10-question test, scored from 10-40, with lower scores representing low self efficacy. * Average US adult values: 29.48 (SD 5.13) * Successful evaluation of Self-Efficacy will be indicated if increases in GSE scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. * The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Evaluating the presence and severity of Alcohol Use Disorders
Time frame: 8 weeks
Assessed via Alcohol Use Disorders Identification Test (AUDIT) electronically administered patient reported outcome questionnaire * A 10-question test with a threshold score >7 considered "AUDIT-positive", indicating risky or hazardous alcohol use behavior. * National data suggests 15-20% of US 14-18 year olds screen positive * Successful evaluation of Alcohol Use Disorders will be indicated if increases in AUDIT scores are found to be significantly associated with increased pain and decreased physical function (HOOS, PROMIS-PI, PROMIS-PB, PROMIS-PF) or increased self-reporting of opioid use. * The finding of no significant association, but increased presence of maladaptive features compared to normative data for US adolescents would also be considered a successful finding.
Changes in Physical Function (PROMIS)
Time frame: 8 weeks
Measured via the following electronically administered patient reported outcome questionnaires. * PROMIS: Physical Function (PF) * Normative T-score generated from US adult population data: mean 50 (SD 10). * For this study, an average T-score <40 would be considered significantly different compared to normative values. * The minimally important difference (MID) of 1.9 - 2.2 calculated from research in nonoperative treatment of knee osteoarthritis will be representative of clinical improvement at eight weeks.
Changes in Physical Function (HOOS)
Time frame: 8 weeks
Measured via the following electronically administered patient reported outcome questionnaires. * The Hip disability and osteoarthritis outcome score (HOOS) * Scored from 0-100 * Increasing score represent better function. * Average scopres for hip preservation patients prior to surgery is well established
Reduced Opioid Use
Time frame: 8 weeks
Measured via self reported opioid use after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Scott, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell Phone Based Cognitive Based Therapy (Pacifica App) in people with Hip Dysplasia and Hip Pain Chronic, run by Michael C Willey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael C Willey (3193561616, michael-willey@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in level of Depression (DASS-21) (time frame: 8 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.